Urgencias y Unidad de Cuidados Coronarios, Instituto Nacional de Cardiología Ignacio Chávez, México.
Unidad de Investigación de Salud en el Trabajo, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social. Ciudad de México, México.
Arch Cardiol Mex. 2020;90(2):158-162. doi: 10.24875/ACM.19000185.
The objective of PHASE-MX registry is to validate the efficacy and safety of the pharmacoinvasive strategy in comparison with percutaneous coronary intervention (PCI) in patients with acute myocardial infarction with ST segment elevation (STEMI) in a metropolitan region of Mexico. The primary outcome will consist of the composite of cardiovascular death, re-infarction, stroke and cardiogenic shock.
The PHASE-MX registry will include a prospective cohort of patients with STEMI who received reperfusion treatment (mechanical of pharmacological) in the first 12 h after the onset of symptoms. The registry is designed to compare the efficacy and safety of primary PCI and pharmacoinvasive strategy. The simple size was calculated in 344 patients divided into two groups, with an estimated loss rate of 10%. Patients included in the PHASE-MX cohort will be followed for up to one year.
In Mexico, only 5 out of 10 patients with STEMI have access to reperfusion therapy. Pharmacoinvasive strategy is takes advantage of the accessibility of fibrinolysis and the effectiveness of PCI. The present research protocol aims to provide information that serves as a link between information derived from controlled clinical trials and records derived from real world experience.
PHASE-MX 注册研究的目的是在墨西哥大都市地区,验证与经皮冠状动脉介入治疗(PCI)相比,药物侵入性策略在急性 ST 段抬高型心肌梗死(STEMI)患者中的疗效和安全性。主要结局将包括心血管死亡、再梗死、卒中和心原性休克的复合事件。
PHASE-MX 注册研究将包括一个前瞻性队列研究,该研究纳入了在症状发作后 12 小时内接受再灌注治疗(机械或药物)的 STEMI 患者。该注册研究旨在比较直接 PCI 和药物侵入性策略的疗效和安全性。根据 344 例患者分为两组,预计失访率为 10%,计算出简单样本量。PHASE-MX 队列中的患者将接受长达一年的随访。
在墨西哥,只有 5/10 的 STEMI 患者能够获得再灌注治疗。药物侵入性策略利用了纤溶酶的可及性和 PCI 的有效性。本研究方案旨在提供信息,作为来自对照临床试验的信息和来自真实世界经验的记录之间的联系。